ADMA Biologics, Inc.
Senior Project Engineer – ADMA Biologics, Inc.
Location: Boca Raton, FL
ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients. We are seeking a Senior Project Engineer to provide engineering, project management, manufacturing, and maintenance support to our GMP manufacturing site.
Position Summary The Senior Project Engineer will troubleshoot, problem‑solve, and implement engineering solutions for existing manufacturing processes and equipment. Responsibilities include evaluating and assisting capital engineering and process improvement projects, and designing, procuring, and commissioning new process and utility equipment.
Essential Functions & Responsibilities
Managing mid‑to‑large sized engineering projects by planning and tracking activities of cross‑functional teams and contractors; developing schedules and performance requirements; and managing project scope, schedule, and cost.
Developing and executing commissioning plans for process and utility systems.
Developing and reviewing process flow diagrams and P&ID drawings for new and modified systems.
Directing or assisting in the design and execution of all capital projects assigned.
Supporting engineering development with load calculations for flow, heating/cooling capacity, pressures, etc.
Utilizing technical writing skills to prepare engineering evaluations, change control documents, testing plans, and CAPAs.
Leading investigations of process systems and equipment to determine root cause and implement corrective actions; using statistical tools to analyze data.
Assisting in PM plan development and troubleshooting manufacturing and utilities equipment.
Serving as the technical liaison for OSHA, regulatory, and other audits related to maintenance/facility aspects.
Assisting in writing regulatory documents for FDA submissions as required.
Creating capital expenditure requests and purchase requisitions prior to procurement.
Competencies & Qualifications
10+ years of engineering experience in a cGMP Pharmaceutical/Biological manufacturing environment.
Advanced knowledge of Microsoft Office (Word, Excel, Project).
Excellent problem‑solving, analytical, and communication skills.
Strong mechanical aptitude and understanding of general maintenance.
Ability to follow cGMP procedures with great attention to detail.
Ability to read and understand blueprints.
Ability to evaluate regulations and recommend procedural changes.
Thrives in high‑pressure, deadline‑driven environments.
Organizational and time‑management skills with ability to balance multiple assignments.
Preferred Experience
Experience in quality system and cGMP initiatives, ensuring compliance with ADMA Quality policies, QA records, HR policies, EH&S procedures.
Familiarity with regulatory requirements for FDA submissions.
Benefits
Competitive compensation.
401K plan with employer match and immediate vesting.
Medical, Vision, Life, and Dental Insurance.
Pet Insurance.
Company‑paid STD and LTD.
Company paid holidays.
3 weeks’ paid time off in the first year.
Tuition assistance after the first year.
Free shuttle to the Boca Tri‑Rail station.
Legal & Equal Opportunity Statement ADMA Biologics uses E‑Verify to confirm the employment eligibility of all newly hired employees. E‑Verify information is available at
www.dhs.gov/E-Verify .
ADMA Biologics is an Equal Opportunity Employer.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Engineering and Information Technology
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ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients. We are seeking a Senior Project Engineer to provide engineering, project management, manufacturing, and maintenance support to our GMP manufacturing site.
Position Summary The Senior Project Engineer will troubleshoot, problem‑solve, and implement engineering solutions for existing manufacturing processes and equipment. Responsibilities include evaluating and assisting capital engineering and process improvement projects, and designing, procuring, and commissioning new process and utility equipment.
Essential Functions & Responsibilities
Managing mid‑to‑large sized engineering projects by planning and tracking activities of cross‑functional teams and contractors; developing schedules and performance requirements; and managing project scope, schedule, and cost.
Developing and executing commissioning plans for process and utility systems.
Developing and reviewing process flow diagrams and P&ID drawings for new and modified systems.
Directing or assisting in the design and execution of all capital projects assigned.
Supporting engineering development with load calculations for flow, heating/cooling capacity, pressures, etc.
Utilizing technical writing skills to prepare engineering evaluations, change control documents, testing plans, and CAPAs.
Leading investigations of process systems and equipment to determine root cause and implement corrective actions; using statistical tools to analyze data.
Assisting in PM plan development and troubleshooting manufacturing and utilities equipment.
Serving as the technical liaison for OSHA, regulatory, and other audits related to maintenance/facility aspects.
Assisting in writing regulatory documents for FDA submissions as required.
Creating capital expenditure requests and purchase requisitions prior to procurement.
Competencies & Qualifications
10+ years of engineering experience in a cGMP Pharmaceutical/Biological manufacturing environment.
Advanced knowledge of Microsoft Office (Word, Excel, Project).
Excellent problem‑solving, analytical, and communication skills.
Strong mechanical aptitude and understanding of general maintenance.
Ability to follow cGMP procedures with great attention to detail.
Ability to read and understand blueprints.
Ability to evaluate regulations and recommend procedural changes.
Thrives in high‑pressure, deadline‑driven environments.
Organizational and time‑management skills with ability to balance multiple assignments.
Preferred Experience
Experience in quality system and cGMP initiatives, ensuring compliance with ADMA Quality policies, QA records, HR policies, EH&S procedures.
Familiarity with regulatory requirements for FDA submissions.
Benefits
Competitive compensation.
401K plan with employer match and immediate vesting.
Medical, Vision, Life, and Dental Insurance.
Pet Insurance.
Company‑paid STD and LTD.
Company paid holidays.
3 weeks’ paid time off in the first year.
Tuition assistance after the first year.
Free shuttle to the Boca Tri‑Rail station.
Legal & Equal Opportunity Statement ADMA Biologics uses E‑Verify to confirm the employment eligibility of all newly hired employees. E‑Verify information is available at
www.dhs.gov/E-Verify .
ADMA Biologics is an Equal Opportunity Employer.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Engineering and Information Technology
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